Auditing Laboratory Data Systems

Duration: 60 Minutes
The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an understanding of the controls that are necessary to ensure the integrity of analytical data.
Laboratory Data Systems
Instructor: Mark Powell
Product ID: 500699

Why Should you Attend:
The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. Businesses will benefit by reducing the risk of regulatory action as a result of failure to comply with current expectations.

Objectives of the Presentation:
The objectives of the presentation are to cover areas such as:
  • Categories of laboratory data system (GAMP)
  • Lifecycle management, archiving and backup
  • What counts as raw data?
  • Protecting the integrity of analytical data
  • General guidance on assigning user privileges
  • Operating system configuration.
  • Application configuration
  • Controls appropriate for chromatography data systems
  • Practices that aid compliance with data integrity requirements
  • Examples from recent FDA warning letters
Who can Benefit:
  • Staff who are required to audit analytical operations who do not have a chemical QC background.
  • Auditors who require updating on current regulatory expectations.
  • QC staff who needs help in regulatory compliance.
  • Staff who would like to understand the implications of data integrity for laboratory data systems.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 20 years' experience as a senior analytical chemist. He is a member of the RSC's Analytical Division Council and chairs their working group on Continuing Professional Development. Until September 2013, he was Scientific Manager for a pharmaceutical CRO specializing in early-stage drug development. He left that job to set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry.
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